WASHINGTON — The Biden administration asked Supreme Court Providing wide access to the most commonly used medicine on Tuesday medication abortionsargues that limiting its presence would harm women across the country.
Both the administration and drugmaker Danco filed briefs outlining their arguments to defend several Food and Drug Administration decisions that, among other things, made it possible to buy the mifepristone pill by mail. Danco makes Mifeprex, a brand-name version of the pill.
“Losing access to mifepristone will be detrimental to women and health care providers across the country,” said Elizabeth Prelogar, the attorney general. summary of government.
“For many patients, mifepristone is the best way to legally terminate an early pregnancy. They may choose mifepristone over surgical abortion because of medical necessity, a desire for privacy, or past trauma,” he said.
Prelogar said FDA approvals are backed not only by scientific research, but also by “decades of safe use of mifepristone by millions of women in the United States and around the world.”
Oral arguments have not yet been scheduled. They will be held in early spring and a decision is expected at the end of June.
The call for approval of mifepristone was brought by a group of doctors and other medical professionals represented by the conservative Christian rights group Alliance Defending Freedom. They say the FDA’s 2000 approval was flawed, in part because it ignored safety risks for women, as were later decisions that eased access to the drug. The FDA and Danco say serious adverse effects are “very rare.”
One separately shortDanco’s attorneys said the questions raised in the case were “not difficult under existing precedent” and “were not asking the court to make political charges about abortion.”
The appeals court’s review decision “threatens to destabilize a pharmaceutical industry that relies both on the FDA’s ability to make predictive judgments and on the courts’ reluctance to defer to those scientific judgments,” the lawyers wrote.
The plaintiffs will submit their reports in the coming weeks.
There are judges has already intervened once, when he completely blocked a decision by U.S. District Court Judge Matthew Kaczmarik in April in Texas. The FDA’s original approval of the drug more than 20 years ago. At the time, conservative Justices Clarence Thomas and Samuel Alito said they would allow part of his decision to stand.
Kacsmarik’s decision threatened the availability of the pill, including by mail order, but the Supreme Court’s ruling meant it remained available as normal while the trial continued.
Since the Supreme Court’s action in April, the case has gone through the appeals process, and the scope has narrowed somewhat to focus on later FDA decisions relaxing the restrictions, rather than the 2000 decision to approve the pill.
When the court agreed last month He turned down a separate petition seeking to challenge the 2000 approval to hear the Biden administration and Danco appeals.
The Supreme Court will look to the FDA’s actions since 2016 to make it easier to get the pill, including the 2021 mail-in preliminary ruling that was finalized last year.
Also under review are the 2016 decisions to extend the window in which mifepristone can be used to terminate pregnancy from seven weeks to 10 weeks and reduce the number of in-person visits for patients from three to one. In another move in 2016, the FDA changed the dosing regimen, finding that a lower dose of mifepristone was sufficient.
In a separate development in the case, three Republican state attorneys general tried to intervene to support the challenge. State officials representing Missouri, Idaho and Kansas are trying to allay concerns that the original plaintiffs lacked legal standing to sue, Prelogar argued in his brief.
The standing issue is important because, in one scenario, the court could simply dismiss the challenge on those grounds, meaning it would not have to decide the meaty questions of FDA approval.
If the court had allowed the states to participate, it would have meant the standing issue would not have been a problem, state attorneys general argued. lawsuit.
The FDA-approved regimen for medication abortion includes two drugs: mifepristone, which blocks the hormone progesterone, and misoprostol, which induces contractions. Most abortions in the United States are performed using the pill.
The mifepristone dispute is one of two abortion cases before the court.
In anotherthe court will decide whether a provision of an Idaho law that can punish doctors who perform emergency abortions conflicts with a federal law on standards of care that applies to any hospital that receives federal funding through the Medicare program.